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FDA 510(k)

SMAC REPLACEMENT REAGENTS/OF BUN-SERUM

K-Number: K800673 · 1980-05-28

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-28
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMAC REPLACEMENT REAGENTS/OF BUN-SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800673. The device is classified under product code CDW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMAC REPLACEMENT REAGENTS/OF BUN-SERUM?

SMAC REPLACEMENT REAGENTS/OF BUN-SERUM is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800673.

When did SMAC REPLACEMENT REAGENTS/OF BUN-SERUM receive FDA 510(k) clearance?

SMAC REPLACEMENT REAGENTS/OF BUN-SERUM received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800673.

Who is the listed applicant for SMAC REPLACEMENT REAGENTS/OF BUN-SERUM?

The FDA 510(k) record lists Diagnostic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMAC REPLACEMENT REAGENTS/OF BUN-SERUM?

The FDA product code for SMAC REPLACEMENT REAGENTS/OF BUN-SERUM is CDW.

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Other records listing Diagnostic Solutions, Inc. as applicant

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K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONK924398UNI-CHECK REAGENT STRIPK921825QUICK-CHECK II REAGENT STRIPK800689REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMK800691REAGENT FOR DETERM. LACTATE/DEHYDROGENAS

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Related Devices (Code: CDW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K874532BLOOD UREA NITROGENCatachem, Inc.K871320FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814American Research Products Co.K863425AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346American Research Products Co.K861775TWIN BUN/GLUCOSEBoehringer Mannheim Corp.K860419UREA NITROGEN REAGENT SETSterling Diagnostics, Inc.K850937UREADilab, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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